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Home> Systems/Procedures> Patents> Examination> Examples of examinations on the inventions related to genes (DNA fragments full-length cDNAs and Single Nucleotide Polymorphisms)(The abridged translation)
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Examples of examinations on the inventions related to genes (DNA fragments, full-length cDNAs, and Single Nucleotide Polymorphisms)(The abridged translation)
The original version of the"Examples of examinations on the inventions related to genes (DNA fragments, full-length cDNAs, and Single Nucleotide Polymorphisms)" is available from the JPO homepage.
When any ambiguity of interpretation is found in this translation, the Japanese original text shall prevail.
Index
- Unity of Invention
- Enablement Requirement :No
- Inventive Step :No
- Inventive Step :No, Enablement Requirement :No
- Inventive Step :Yes, Enablement Requirement :Yes
1. Unity of Invention
Case 1 DNA fragments (Unity of invention :no)
[Claims]
- A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:1.
- A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:2.
[Description of the invention]
Both of the claimed 500bp polynucleotides were derived from the same cDNA library constructed from human liver.
Both of the claimed polynucleotides are part of structural genes, and they can be used as probes in one of the steps to obtain the full-length DNAs.
The nucleotide sequence of SEQ ID NO:1 showed 5% homology to the nucleotide sequence of SEQ ID NO:2.
[Result of the prior-art search]
The nucleotides derived from human liver are known.
[Reason for rejection (Unity of invention)]
As there are so many known polynucleotides derived from human liver, the mere fact that these DNA sequences have the same source does not mean that these sequences have the same technical problem to be solved because the technical problem must be the one which is unsolved before the filing.
Furthermore, it cannot be said that substantial parts of the matters stated in the claims are the same since the nucleotide sequence of SEQ ID NO:1 showed 5% homology to the nucleotide sequence of SEQ ID NO:2.
In this case, therefore, unity of invention cannot be acknowledged.
(Attention)
If the application does not comply with the requirement of unity of invention, the invention set forth in the first claim (and those inventions having unity with the said invention) should be examined in respect of other requirements (novelty, inventive step, enablement requirement, etc.)
Please refer to the case 7 in respect of other requirements.
Case 2 DNA fragments (Unity of Invention :yes)
[Claims]
- A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:3.
- A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:4.
[Description of the invention]
These polynucleotides are the 500bp cDNAs which were found in cDNA library derived from hepatocyte of patients with disease Y but not found in those of normal persons.
It was confirmed by northern hybridization that the corresponding mRNAs were expressed only in the patients' hepatocyte. Therefore, these polynucleotides can be used as probes to diagnose disease Y.
The nucleotide sequence of SEQ ID NO:3 showed 5% homology to the nucleotide sequence of SEQ ID NO:4.
[Result of the prior-art search]
There is no known polynucleotide or protein which are unique in the patients with disease Y.
[Reason for rejection (unity of invention)]
No reason for rejection
(Attention)
Since both of the claimed inventions are related to specific DNAs in the patients with disease Y, the field of industrial application is considered to be the same.
And both of the claimed inventions have the same problem to be solved that they provide for the first time multiple group of polynucleotides which are specific to patients with disease Y because no such DNA was known before the time of filing.
Therefore, these claims have unity of invention.
Please refer to case 9 in respect of other requirements.
2.Enablement Requirement :NO
Case 3 Full-length cDNA
[Claim1]
A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:5.
[Description of the invention]
The claimed polynucleotide is 3000bp cDNA obtained from human liver cDNA library. It encodes a polypeptide of amino acid sequence of SEQ ID NO:6.
As a result of similarity search, no known sequences showed over 30% similarity to the nucleotide sequence of SEQ ID NO:5 or the amino acid sequence of SEQ ID NO:6.
The amino acid sequence of SEQ ID NO:6 was proved to have a potential site of glycosylation.
Therefore, the claimed polynucleotide is assumed to be a structural gene encoding a new glycoprotein, whose specific function is unknown, and may be used for obtaining a new drug.
[Result of the prior-art search]
There is no known nucleotide sequence with over 30% similarity to that of SEQ ID NO:5.
There is no known amino acid sequence with over 30% similarity to that of SEQ ID NO:6.
[Reason for rejection]
Even if the claimed polynucleotide encodes glycoprotein, the corresponding glycoprotein's specific function cannot be recognized because there are so many glycoproteins whose specific function differs from each other.
The specific function of the claimed polynucleotide also cannot be assumed with the common general knowledge.
As the specific function of the claimed polynucleotide is not clear, it is not clear how to use the claimed polynucleotide.
Therefore, there is no disclosure concerning the use of the claimed polynucleotide, thus, the description of the invention is deemed insufficient for enabling a person skilled in the art to carry out the invention.
(Attention)
The above mentioned reason for rejection normally shall not be overcome.
Case 4 Full-length cDNA
[Claim1]
A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:7.
[Description of the invention]
The claimed polynucleotide is 2400bp cDNA obtained from human liver cDNA library.
It encodes a polypeptide of 800 amino acids of SEQ ID NO.8.
As a result of similarity search using a known DNA and amino acid database, the claimed polynucleotide showed 20 to 30% homology to the polynucleotides encoding factor WW1 of mammalians such as rats. The polynucleotides are written in document A, document B, etc. And the amino acid sequence of SEQ ID NO:8 showed 20 to 30% homology to the amino acid sequences of factor WW1 of mammalians such as rats. The amino acid sequences are also written in document A, document B, etc.
Therefore, the claimed polynucleotide was assumed to encode human factor WW1 and to be useful.
[Result of the prior-art search]
There is no known sequence with over 40% similarity to the nucleotide sequence of SEQ ID NO:7 or the amino acid sequence of SEQ ID NO:8.
[Reason for rejection]
The given reason by the applicant that this polynucleotide encodes human factor WW1 is only based on the fact that the claimed polynucleotide has 20 to 30% homology to other mammalian polynucleotides encoding factor WW1 and that the amino acid sequence of SEQ ID NO:8 has 20 to 30% homology to amino acid sequences of factor WW1 of other mammalians.
In general, when two polynucleotides (polypeptides) show only 20-30% homology to each other, they probably do not have any specific function in common. And there is no common general knowledge that the human polynucleotide, with only 20-30% homology to the polynucleotide of factor WW1, encodes human factor WW1.
As the claimed polynucleotide probably does not encode human factor WW1, the specific function of the claimed nucleotide is not clear and no one can assume the specific function of the protein encoded by the nucleotide.
Therefore, we consider there is no disclosure concerning the use of this polynucleotide in an industrial applicable way, thus the description of the invention is deemed insufficient for enabling a person skilled in the art to carry out the invention.
(Attention)
If the claimed polynucleotide is proved as encoding human factor WW1 by written argument or certified experiment results, the above mentioned reason for rejection may be overcome. But other reasons for rejection (inventive step) will be examined.
Case 5 Full-length cDNA
[Claim1]
A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:9.
[Description of the invention]
The claimed polynucleotide is 2400bp cDNA obtained from human liver cDNA library.
It encodes a polypeptide of 800 amino acids of SEQ ID NO:10.
As a result of similarity search using a known DNA and amino acid database, the claimed polynucleotide showed 20 to 30% homology to the polynucleotide encoding factor ZZ1 of rat, factor ZZ2 of pig and an antagonist of factor ZZ1 receptor of monkey. And the amino acid sequence of SEQ ID NO:10 showed 20 to 30% homology to factor ZZ1 of rat, factor ZZ2 of pig and an antagonist of factor ZZ1 receptor.
Therefore, this polynucleotide encodes a human protein related to factor ZZ and may be used to diagnose patients with disease related to factor ZZ.
[Result of the prior-art search]
There is no known sequence with over 40% similarity to the nucleotide sequence of SEQ ID NO:9 or the amino acid sequence of SEQ ID NO:10.
[Reason for rejection]
As factor ZZ1, factor ZZ2, and antagonist of factor ZZ1 receptor have a different specific function to each other, mere description that the claimed polynucleotide encodes protein relating to factor ZZ does not indicate any specific function of the claimed polynucleotide.
And the specific function of the corresponding protein cannot be assumed considering the state of the art as of the filing.
Therefore we consider there is no disclosure concerning the use of this polypeptide in an industrial applicable way, thus the description of the invention is deemed as insufficient for enabling a person skilled in the art to carry out the invention.
(Attention)
Even if the claimed polynucleotide is proved as encoding human protein ZZ1 by written argument or certified experiment results, the reason for rejection above may not be overcome.
3. Inventive Step :No
Case 6 Full-length cDNA
[Claim 1]
A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:11.
[Description of the invention]
The claimed polynucleotide is 2700bp cDNA obtained from human liver cDNA library. It encodes a polypeptide of 900 amino acids of SEQ ID NO:12.
As a result of similarity search, the amino acid sequence of SEQ ID NO:12 showed 85% homology to rat factor XX1(written in document A) and the polynucleotide sequence of SEQ ID NO:11 showed 80% homology to the polynucleotide encoding rat factor XX1(written in document A).
Therefore, this polynucleotide was assumed to encode human factor XX1 and to be useful.
[Result of the prior-art search]
There was no other sequence detected with over 80% similarity to that nucleotide sequence or polypeptide sequence except for rat polynucleotide encoding rat factor XX1 or the amino acid sequence of rat factor XX1.
It is a well-known fact that mammalians including human have factor XX1.
[Reason for rejection]
It is a well-known object to prepare human DNAs encoding proteins.
It is also common general knowledge to isolate the human DNA encoding a certain protein by using a partial nucleotide sequence of a mammal other than human encoding the same protein as a primer probe. Since polynucleotide encoding proteins with the same biological activities are in general highly homologous between mammalian species.
Therefore, it is obvious that the DNA encoding human factor XX1 can be isolated from human cDNA library using the partial polynucleotide encoding rat factor XX1 written in document A as a primer.
And any advantageous effect cannot be acknowledged from document A or common general knowledge, hence this invention cannot be regarded as involving an inventive step.
(Attention)
The reasons for rejection above shall be determined to overcome if the applicant show specific difficulty to obtain the claimed polynucleotide with the state of the art as of the filing.
4. Enablement Requirement :No, Inventive Step :No
Case 7 DNA fragment
[Claim 1]
A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:13.
[Description of the invention]
A cDNA library was constructed from human liver using oligo (dT) primers. The nucleotide sequence of SEQ ID NO:13 is one of the sequences (500 bp) which were analyzed using an automated DNA sequencer.
The polynucleotide consisting of the nucleotide sequence of SEQ ID NO:13 is part of a structural gene, and it can be used as a probe in one of the steps to obtain the full-length DNA.
However, there is no working example indicating that the full-length DNA was actually obtained, and there is no description of the function or biological activity of the DNA and its corresponding protein.
[Result of the prior-art search]
There is no known sequence with over 30% similarity to the nucleotide sequence of SEQ ID NO:13 or the amino acid sequence of SEQ ID NO:14.
[Reason for rejection]
1. Inventive Step:No
It is a well-known object to obtain cDNAs from human cells and sequence them.
It is also a well-known art to construct cDNA libraries from human organs, such as the liver, and to analyze the sequence of cDNA randomly chosen from the library with the use of an automated sequencer.
Therefore, for a person skilled in the art, it would have been easy to prepare cDNA library and to sequence cDNAs derived from the library using conventional methods. And the obtained DNA does not have an unexpected advantageous effect.
Hence, this invention cannot be regarded as involving an inventive step.
2. Enablement Requirement:No
An invention of a product should be described in a way enabling for a person skilled in the art to make and to use the product in an industrially applicable way. (except where the product could be made and used by a person skilled in the art without such explicit description by taking into account the overall descriptions of the specification, drawings and common general knowledge as of the filing.)
There is a description that the claimed DNA can be used as a probe in one of the steps to obtain a full-length DNA. However, there is no description on function or biological activity of the protein encoded by the corresponding full-length DNA. Moreover, function or biological activity of the full-length DNA cannot be assumed with common general knowledge as of the filing.
The use of a DNA fragment in obtaining the full-length DNA, whose corresponding protein's function and biological activity are unknown, is not considered to be an industrially applicable use.
We consider there is no disclosure concerning the use of the DNA fragment in an industrially applicable way, thus the description of the invention is deemed insufficient for enabling a person skilled in the art to carry out the invention.
(Attention)
The reasons for rejection 2 above normally shall not be overcome.
Case 8 SNPs
[Claim1]
A polynucleotide of between 20 and 100 bases including position 100 (polymorphic site) of the nucleotide sequence of SEQ ID NO:14 or SEQ ID NO:15.
[Description of the invention]
The polynucleotide of the locus of the human genome DNAs derived from 10 persons were compared to each other. Six of 10 polynucleotide were SEQ ID NO:14 and four of 10 were SEQ ID NO:15.
The nucleotide at position 100 of SEQ ID NO:14 is g. On the other hand, that of SEQ ID NO:15 is c. These two nucleotide sequences are the same except for the nucleotide at position 100.
The claimed polynucleotide can be used as a forensic marker.
[Result of the prior-art search]
The nucleotide sequence of SEQ ID NO:14 and NO:15 are unknown.
The claimed polyuncleotide is also unknown.
[Reason for rejection]
1. Inventive step:No
It is a well-known object to detect polymorphic site in human genome DNA.
It is a well-known art to analyze and compare the sequences of genome DNAs of many persons, to detect a polymorphic site.
Therefore, for a person skilled in the art, it would have been easy to analyze and compare the sequences of a certain part of genome DNAs of several persons and to detect the polymorphic site.
And any unexpected advantageous effect cannot be acknowledged, hence this invention cannot be regarded as involving an inventive step.
2. Enablement requirement:No
An invention of a product should be described in a way enabling for a person skilled in the art to make and to use the product in an industrially applicable way. (except where the product could be made and used by a person skilled in the art without such explicit description by taking into account the overall descriptions of the specification, drawings and common general knowledge as of the filing.)
Though, there is a description that the claimed nucleotide can be used as a forensic marker, only one SNP itself is not usually utilized as a forensic marker. Therefore, the mere description that the polynucleotide can be used as a forensic marker does not indicate any industrial applicable use of the claimed polynucleotide.
(Attention)
The reasons for rejection 2 above normally shall not be overcome.
5. Enablement Requirement :Yes, Inventive Step :Yes
Case 9 DNA fragment
[Claim 1]
A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:16.
[Description of the invention]
The polynucleotide is one of the 500bp cDNAs which were found in a cDNA library derived from the hepatocyte of patients with disease Y, but not found in those of normal persons.
It was confirmed by northern hybridization that the corresponding mRNAs were expressed only in the patients' hepatocyte. Therefore, the polynucleotide can be used to diagnose disease Y.
[Result of the prior-art search]
There is no known DNA and polypeptide which are unique in the patients with disease Y.
There is no known sequence with over 30% similarity to the nucleotide sequence of SEQ ID NO:16.
[Reason for rejection]
No reason for rejection
Case 10 Full-length cDNA
[Claim1]
A polynucleotide consisting of the nucleotide sequence of SEQ ID NO:17.
[Description of the invention]
The claimed polynucleotide is 2700bp cDNA obtained from human liver cDNA library. It encodes a polypeptide of 900 amino acids of SEQ ID NO:18. This polypeptide was expressed and it showed the activity of human factor YY1.
[Result of the prior-art search]
There is no known sequence with over 80% similarity to the nucleotide sequence of SEQ ID NO:17 or the amino acid sequence of SEQ ID NO:18. And no prior art was found about the human factor YY1.
[Reason for rejection]
No reason for rejection
(Attention)
The specific function of the factor YY1 is known.
Case 11 SNP
[Claim1]
A polynucleotide of between 20 and 100 bases including position 50(g) (polymorphic site) of the nucleotide sequence of SEQ ID NO:19.
[Description of the invention]
The polynucleotide of SEQ ID NO:20 is known.
The nucleotide at position 50 of SEQ ID NO:19(500 length DNA) is g. On the other hand, that of SEQ ID NO:20 is c. These two nucleotides are the same except for the nucleotide at position 50.
The nucleotide at position 50 of the polynucleotide of SEQ ID NO:19 is proved to be polymorphic site.
A polynucleotide of between 20 and 100 bases including position 50 (g) of the nucleotide sequence of SEQ ID NO:19 is experimentally proved to be used to diagnose disease Z.
[Result of the prior-art search]
The polynucleotide sequence of SEQ ID NO:19 was not known. The claimed polynucleotide was neither known.
Relationship between the polymorphic site at position 50 and disease Z was not known.
Though the polynucleotide of SEQ ID NO:20 is known to be a part of structural gene, the relationship between the protein encoded by the structural gene and disease Z was not known.
[Reason for rejection]
No reason for rejection
[Last updated 26 November 1999]
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